Introduction
The litigation between BioDelivery Sciences International, Inc. (BDSI) and Teva Pharmaceuticals USA Inc. revolves around patent infringement claims related to the pharmaceutical drug product Belbuca® (buprenorphine buccal film). Here, we delve into the key aspects of this case, including the background, legal arguments, and the eventual settlement.
Background
BioDelivery Sciences International, Inc., along with Arius Two, Inc., and Endo Pharmaceuticals Inc., filed a complaint against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd. in the United States District Court for the District of Delaware. The complaint alleged patent infringement under 35 U.S.C. §§ 271(e)(2), (a), (b), and (c) concerning the '019 patent, which pertains to the method of use of buprenorphine buccal film[1].
Jurisdiction and Venue
The plaintiffs argued that the court had personal jurisdiction over Teva USA due to several factors, including its incorporation in Delaware, registration to do business in Delaware, and the sale and distribution of generic drugs in Delaware. Additionally, Teva Ltd. was alleged to have continuous and systematic contacts with Delaware, further establishing jurisdiction[1].
Patent Infringement Claims
The core of the litigation centered on the infringement of the '019 patent. The plaintiffs claimed that if the FDA approved Teva's Abbreviated New Drug Applications (ANDA Nos. 209704 and 209772), Teva would sell or offer to sell their generic buprenorphine buccal film, which would contribute to the infringement of the '019 patent. The plaintiffs argued that this generic product would be used in practicing one or more of the method claims of the '019 patent, and since buprenorphine buccal film is not a staple article or commodity suitable for substantial noninfringing use, Teva's actions would constitute infringement[1].
Legal Arguments and Proceedings
Teva's defense likely involved challenging the validity of the '019 patent, a common strategy in patent infringement cases. However, the specific details of Teva's arguments in this case are not as extensively documented as in other similar cases, such as the one involving Janssen Pharmaceuticals and Teva, where Teva argued that the claims were invalid as obvious and indefinite[3].
Settlement Agreement
The litigation was resolved through a settlement agreement. Under the terms of the settlement, Teva was allowed to market its generic version of Belbuca in the U.S. starting on January 23, 2027, or earlier under certain circumstances. This agreement was reached in 2018, and it marked the end of the patent dispute between BDSI and Teva[2][5].
Impact on the Parties
The settlement had immediate financial implications for BDSI, with its shares rising 4% in premarket trading following the announcement. This increase reflects the market's positive reaction to the resolution of the litigation, which removed a significant uncertainty for the company[2].
Broader Implications
This case highlights the complexities and challenges associated with pharmaceutical patent litigation. The settlement underscores the importance of negotiating agreements that balance the interests of both the innovator company and the generic manufacturer. It also demonstrates how such agreements can impact the timeline for generic drug entry into the market, which is crucial for both patient access and market competition.
Key Takeaways
- Patent Infringement Claims: The litigation centered on the infringement of the '019 patent related to the method of use of buprenorphine buccal film.
- Jurisdiction and Venue: The court had personal jurisdiction over Teva USA and Teva Ltd. due to their significant contacts with Delaware.
- Settlement Agreement: Teva was allowed to market its generic version of Belbuca starting on January 23, 2027, or earlier under certain circumstances.
- Financial Impact: The settlement led to a positive market reaction, with BDSI's shares rising 4% in premarket trading.
- Broader Implications: The case emphasizes the complexity of pharmaceutical patent litigation and the importance of negotiated settlements in balancing innovator and generic manufacturer interests.
FAQs
Q: What was the main issue in the litigation between BioDelivery Sciences International, Inc. and Teva Pharmaceuticals USA Inc.?
A: The main issue was the alleged infringement of the '019 patent related to the method of use of buprenorphine buccal film by Teva's proposed generic product.
Q: Why did the court have jurisdiction over Teva USA and Teva Ltd.?
A: The court had jurisdiction due to Teva USA's incorporation in Delaware, registration to do business in Delaware, and significant sales and distribution activities in the state. Teva Ltd. also had continuous and systematic contacts with Delaware.
Q: What were the terms of the settlement agreement?
A: Under the settlement, Teva was allowed to market its generic version of Belbuca in the U.S. starting on January 23, 2027, or earlier under certain circumstances.
Q: How did the settlement impact BioDelivery Sciences International, Inc.?
A: The settlement led to a 4% increase in BDSI's shares in premarket trading, reflecting a positive market reaction to the resolution of the litigation.
Q: What are the broader implications of this case for pharmaceutical patent litigation?
A: The case highlights the complexity of such litigation and the importance of negotiated settlements in balancing the interests of innovator companies and generic manufacturers, which can impact patient access and market competition.
Cited Sources
- United States District Court for the District of Delaware, BioDelivery Sciences International, Inc., Arius Two, Inc., and Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA Inc. and Teva Pharmaceutical Industries Ltd., C.A. No. 1:13-cv-01148-LPS (D. Del. 2013).
- Investing.com, Biodelivery Sciences settles Belbuca patent dispute with Teva, February 6, 2018.
- United States Court of Appeals for the Federal Circuit, Janssen Pharmaceuticals, Inc. v. Teva Pharmaceuticals Usa, Inc., April 1, 2024.
- American University Washington College of Law, Brief for the Coalition Against Patent Abuse as Amicus Curiae in BioDelivery Sciences International, Inc. v. RB Pharmaceuticals Ltd..
- BizJournals, BDSI settles patent litigation with generic giant Teva, October 12, 2017.
